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Femtosecond Laser-assisted Corneal Debridement for Herpes Simplex Keratitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03217474
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : February 22, 2018
Information provided by (Responsible Party):
Chunxiao Wang, Sun Yat-sen University

Brief Summary:
The purpose of the study is to learn if adding femtosecond laser-assisted corneal debridement to a standard therapy of oral ganciclovir can help shorten the healing time of herpes simplex epithelial keratitis (HSK).

Condition or disease Intervention/treatment Phase
Herpes Simplex Keratitis Procedure: FLDEB Drug: Ganciclovir (GCV) Device: Femtosecond laser Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Clinical Trial of Corneal Debridement for the Treatment of Herpes Simplex Epithelial Keratitis
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herpes Simplex
Drug Information available for: Ganciclovir

Arm Intervention/treatment
Experimental: FLDEB combined with GCV orally
Femtosecond laser-assisted cornea debridement (FLDEB) combined with ganciclovir (GCV) orally.
Procedure: FLDEB
The eye will be anesthetized, and femtosecond laser technology will be used to remove epithelial tissue (diameter: 8mm; depth: 100micron) that includes the loosened diseased corneal epithelial cells. Antibiotic ointments and drops will be instilled postoperatively.
Other Name: Femtosecond laser-assisted corneal debridement

Drug: Ganciclovir (GCV)
Patient will be treated with GCV orally (200mg, 3 times a day, for 14 days).

Device: Femtosecond laser
A commercial femtosecond laser to create a particular shaped graft for transplantation.

Active Comparator: GCV orally
Ganciclovir (GCV) orally only
Drug: Ganciclovir (GCV)
Patient will be treated with GCV orally (200mg, 3 times a day, for 14 days).

Primary Outcome Measures :
  1. Healing time [ Time Frame: 14 ± 1 days ]
    Time to complete corneal epithelial healing

Secondary Outcome Measures :
  1. Corneal re-epithelization [ Time Frame: 14 ± 1 days ]
    Assessing complete corneal re-epithelization at day 14±1 using slit-lamp microcopy

  2. Corneal opacity and vascularization [ Time Frame: Baseline, 14 ± 1 days, 3 months ]
    Assessing corneal opacity and vascularization using slit-lamp microcopy

  3. Best-corrected visual acuity [ Time Frame: Baseline, 14 ± 1 days, 3 months ]
    Assessing best-corrected visual acuity using ETDRS chart

  4. Corneal power and astigmatism [ Time Frame: Baseline, 14 ± 1 days, 3 months ]
    Assessing changes of corneal power and astigmatism using autorefractor keratometer

  5. Corneal sensation [ Time Frame: Baseline, 14 ± 1 days, 3 months ]
    Assessing corneal sensation using Cochet-Bonnet esthesiometer

  6. Recurrence [ Time Frame: 3 months ]
    Assessing recurrent HSK using slit-lamp microcopy

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Aged between 18 and 80 years old;
  2. Epithelial ulceration in a dendritic or geographic pattern, characteristic of infection with herpes simplex virus, and within 7 days of onset;
  3. Ulcer's stromal involvement < 120 micron, as indicated by anterior segment optical coherence tomography;
  4. Informed consent signed by patient or legal guardian. Having the ability to comply with study assessments for the full duration of the study.

Exclusion Criteria:

  1. Clinical signs of a cause other than herpes simplex virus for the epithelial keratitis;
  2. Antivirus or corticosteroid treatment within 6 months;
  3. Active stromal keratitis or iritis;
  4. History of allergy or adverse reaction to ganciclovir;
  5. High myopia with a spherical equivalent of -15.0 D or less;
  6. Corneal or ocular surface infection within 30 days prior to study entry;
  7. Ocular surface malignancy;
  8. Uncontrolled diabetes with most recent Hemoglobin A1c greater than 8.5%;
  9. Renal failure with creatinine clearance< 25ml/min;
  10. Alanine aminotransferase > 40IU/L, or aspartate aminotransferase > 40IU/L;
  11. Platelet levels < 150,000 or > 450,000 per microliter;
  12. Hemoglobin < 12.0 g/dL (male) or < 11.0 g/dL (female);
  13. Prothrombin time > 16s and activated partial thrombin time > 35s in patients not accepting anticoagulant therapy; An international normalized ratio greater than 3 in patients accepting anticoagulant therapy;
  14. Pregnancy (positive test) or lactation;
  15. Participation in another simultaneous medical investigation or clinical trial;
  16. Severe cicatricial eye disease; Conjunctival scarring with fornix shortening;
  17. Severe dry eye disease as determined by Schirmer's test < 2mm at least in one eye;
  18. Any medical or social condition that in the judgement of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent;
  19. Active immunological diseases;
  20. History of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03217474

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Contact: Yingfeng Zheng, M.D.Ph.D. +8613922286455

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China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity Recruiting
Guangzhou, Guangdong, China, 5
Contact: Yingfeng Zheng, M.D. Ph.D.         
Sponsors and Collaborators
Chunxiao Wang
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Principal Investigator: Yizhi Liu, M.D.Ph.D. Zhongshan Ophthalmic Center, Sun Yat-sen University
Principal Investigator: Ting Huang, M.D.Ph.D. Zhongshan Ophthalmic Center, Sun Yat-sen University

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Responsible Party: Chunxiao Wang, Clinical investigator, Sun Yat-sen University Identifier: NCT03217474    
Other Study ID Numbers: 2017KYPJ052
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Herpes Simplex
Keratitis, Herpetic
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Corneal Diseases
Eye Diseases
Eye Infections, Viral
Eye Infections
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action